Description
Specimen
|
Whole blood, plasma, serum
|
Method
|
Colloidal Gold immune chromatographic assay
|
Dosage Form
|
In Vitro Diagnostic Medical Rapid Test Cassette
|
Reading Time
|
within 10-15 mins
|
Format
|
Strip or Cassette
|
Certification
|
ISO9001/ ISO13485
|
Shelf Time
|
24 months
|
Package
|
25 tests/box
|
INTENDED USE
The hCG One Step Pregnancy Test Device (Urine) is a rapid, one‐step lateral flow immunoassay in device format for the qualitative detection of human chorionic gonadotropin (hCG) in urine to aid in the detection of pregnancy. The test utilizes a combination of antibodies including a monoclonal hCG antibody to selectively detect elevated levels of hCG. The assay is conducted by adding urine to the specimen well, and obtaining the result from the colored lines.
1.Q: How does the test work? A: The hCG One Step Pregnancy Test Device (Urine) detects a hormone in your urine that your body produces during pregnancy (hCG‐human chorionic gonadotropin).
2.Q: Do I have to test with first morning urine?
A: your first morning urine is usually the most concentrated and have the most hCG in it.
3.Q: How do I know that the test was run properly?
A: The appearance of a colored line in the control region (C) tells.
Operating Steps
1) Add the extracted buffer into the sample well.
2) Wait for the colored band to appear. The result should be read at 10 minutes.
2) Wait for the colored band to appear. The result should be read at 10 minutes.